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PubMed2002

Vaccine candidates in STD.

Sexually transmitted diseases (STDs) are caused by organisms that infect the mucosal surfaces of the genitourinary tract. In spite of its public health importance, current STD vaccine research lags behind work against pathogens that target another mucosal region, the respiratory tract. In the latter case, live-attenuated viral vaccines, killed whole-cell bacterial vaccines, subunit/protein bacterial vaccines, and bacterial polysaccharide vaccines have been enormously successful. To move STD vaccine research forward, complex issues must be resolved. Those include selection of an appropriate antigen (e.g. scientific feasibility and intellectual property rights), the manufacture of the vaccine (e.g. delivery systems, formulation processes, and production steps), and the appropriate public health approach (e.g. medical indications and marketing aspects). Particular scientific problems have delayed STD vaccine development, like incomplete attenuation (human herpes simplex virus type 2), accentuated immunopathology (Chlamydia trachomatis), poor immunogenicity (Treponema pallidum), and broad antigenic heterogeneity (Neisseria gonorrhoeae). Nevertheless, efforts continue with the use of protein antigens: for example, the haemolysin toxoid of Haemophilus ducreyi; the major outer membrane protein(s) of N. gonorrhoeae and C. trachomatis; the glycoprotein D of human herpes simplex virus type 2; and the proteins E6 and E7 of human papilloma virus. It may be predicted that eventual STD vaccines (administered either for prophylaxis or for therapy) will use approaches that include (1) live-attenuated viruses, (2) subunit proteins or inactivated whole organisms given with mucosal adjuvants or with cellular immune response adjuvants, and (3) DNA plasmids expressing the vaccine antigen.

Bacterial Vaccines↗
PubMed2005

MPEG-21 as an access control tool for the National Health Service Care Records Service.

Since the launch of the National Health Service (NHS) Care Records Service with plans to share patient information across England, there has been an emphasis on the need for manageable access control methods. MPEG-21 is a structured file format which includes an Intellectual Property Management and Protection (IPMP) function using XML to present all digitally stored items in the patient record. Using DICreator software, patient records consisting of written text, audio-recordings, non-X-ray digital imaging and video sequences were linked up successfully. Audio records were created using Talk-Back 2002 to standardize and optimize recording quality. The recorded reports were then linked and archived using iTunes. A key was used each time the file was displayed to secure access to confidential patient data. The building of the correct file structure could be monitored during the entire creation of the file. The results demonstrated the ability to ensure secure access of the MPEG-21 file by both health-care professionals and patients by use of different keys and a specific MPEG-21 browser. The study also showed that the enabling of IPMP will provide accurate audit trails to authenticate appropriate access to medical information.

Computer Security↗
PubMed2004

Retaining and transferring nursing knowledge through a hospital internship program.

In healthcare, organizations recognize that human capital is their most valuable asset. The importance of investing in knowledge workers is imperative given the current and future shortage of health professionals. Knowledge acquisition occurs through continuous learning and the transfer of information from those who are highly experienced to those who are less qualified. At St. Michael's Hospital, two innovative and unique programs were created for the transfer of knowledge. The first was a nurse fellowship program that enabled experienced nurses to spend two to three months learning new skills to advance clinical practice. The second was a nurse internship program in which new graduates spend three to four months in their area of hire to enhance clinical practice through skill development and prioritization of patient care needs. This paper describes both programs and presents an evaluation of the new-graduate internship program as an opportunity for professional development and career enhancement For nurse interns, the program promotes self-esteem and professional confidence, improves job satisfaction and rewards nurses for their contribution. For nurse preceptors, the program provides job enrichment, experience in teaching and recognition by the organization and peers that they are knowledge experts. In healthcare, organizations have come to acknowledge that their most valuable asset is human capital, in particular, knowledge workers (Horibe 1999). Knowledge workers contribute a composite of information, intellectual property and experience (Horibe 1999), acquired by study, investigation, observation or practice (Webster's Dictionary 1989). Investing in knowledge workers is investing in the future. In this regard, organizations have implemented recruitment and retention strategies to attract, retain and advance the highest calibre of health professional. Knowledge workers contribute to an organization through their ideas, analyses of complex situations and sound judgment in decision-making (Horibe 1999). They further develop these skills over the course of their career through continuous learning. This paper will focus on the importance of investing in nurses as knowledge workers. In particular, given the shortage of nurses and the reality that 25% of today's nurses can retire over the next 10 years (CNA 2001), it is imperative that knowledge transfer occur from highly experienced to less experienced nurses.

Attitude of Health Personnel↗
PubMedDate not supplied

Value of pharmaceuticals: ensuring the future of research and development.

OBJECTIVE: To analyze the current situation under which the pharmaceutical industry is criticized for the production of drugs with potential adverse effects, the high prices of medicines, and aggressive marketing practices, and to provide a proposal to rectify the situation. DATA SOURCES: Published books, pharmaceutical journals, Web of Science database using the search terms pharmaceutical, research, development, marketing, cost, and the Food and Drug Administration (FDA) Web site. SUMMARY: Most breakthroughs in the treatment of diseases and prolongation of lives have come about through pharmaceuticals discovered and developed by the pharmaceutical industry. While the process of discovering and developing new pharmaceuticals is lengthy, costly, and lacking any assurance of success, investment in research and development by the U.S. pharmaceutical industry has increased progressively, reaching 51.3 billion dollars in 2005. Yet the annual number of FDA approvals of new molecular entities (NMEs) has gradually decreased over the past 10 years. Additionally, a large part of the patent life of a successful NME is consumed during this lengthy development phase. Few businesses, if any, have such long product gestation lives and risks. For these reasons, the pharmaceutical industry is often in a rush to recoup its investment before the product's patent expires, and this is the root cause of many criticisms against the pharmaceutical industry. To rectify the current situation, a new system is proposed under which innovator pharmaceutical companies would be allowed royalties for their products after the expiration of patents, in a manner similar to the way in which other intellectual properties (such as books, music, films) are protected by copyright. Such a system would allow pharmaceutical companies to continue research on new pharmaceutical products unimpeded by the patent clock. CONCLUSION: Given appropriate legislative or other facilitatory actions, a royalty-based system for the marketing of generic products after the expiration of initial patents has the potential to promote innovation, provide for more thorough clinical studies, reduce prices, and share know-how. In addition, some of the issues related to the so-called aggressive pharmaceutical marketing practices would be resolved.

Biomedical Research↗
PubMed2002

In the high court of South Africa, case no. 4138/98: the global politics of access to low-cost AIDS drugs in poor countries.

In 1998, 39 pharmaceutical manufacturers sued the government of South Africa to prevent the implementation of a law designed to facilitate access to AIDS drugs at low cost. The companies accused South Africa, the country with the largest population of individuals living with HIV/AIDS in the world, of circumventing patent protections guaranteed by the intellectual property rules that were included in the latest round of world trade agreements. The pharmaceutical companies dropped their lawsuit in the spring of 2001 after an avalanche of negative publicity. Yet, despite the government's victory, AIDS drugs remain very expensive in South Africa, and the government still refuses to provide antiretroviral therapy to adults. These events have shone a spotlight, not only on the possibilities for coordinated political activism in the era of instant global communications, but also on the tangled social, economic, and political dimensions of AIDS treatment in poor countries.

Acquired Immunodeficiency Syndrome↗
PubMed2004

Social contract theory and just decision making: lessons from genetic testing for the BRCA mutations.

Decisions about funding health services are crucial to controlling costs in health care insurance plans, yet they encounter serious challenges from intellectual property protection--e.g., patents--of health care services. Using Myriad Genetics' commercial genetic susceptibility test for hereditary breast cancer (BRCA testing) in the context of the Canadian health insurance system as a case study, this paper applies concepts from social contract theory to help develop more just and rational approaches to health care decision making. Specifically, Daniel's and Sabin's "accountability for reasonableness" is compared to broader notions of public consultation, demonstrating that expert assessments in specific decisions must be transparent and accountable and supplemented by public consultation.

Breast Neoplasms↗
PubMedDate not supplied

TRIPS and the global pharmaceutical market.

This paper reviews the international controversy over patents and access to drugs in developing countries and explores the implications of the 1995 Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement, the 2001 Doha Declaration, and the 2003 agreement preceding the Cancun meeting. These agreements do not resolve the important funding issues that developing countries confront as they seek access to drugs. Also, the international debate and its resolution will complicate the importing of foreign pharmaceuticals into the United States and strengthen pressures both for expanding public support of U.S. drug purchases and, in the long run, for political control of U.S. pharmaceutical pricing.

Biomedical Research↗
PubMedDate not supplied

Competition: an antidote to the high price of prescription drugs.

Patent protection and factors unique to prescription drugs weaken the forces keeping prices near costs for other products. A growing public consensus that affordable drugs should be available to all is likely to increase the upward pressure on prices. To restore competition to all parts of the pharmaceutical industry, we propose a new institute at the National Institutes of Health that would compete with the private sector for pharmaceutical intellectual property by establishing competition for research and development contracts open to public and private institutions; retain the resulting patents; and grant cost-free, nonexclusive licenses to all qualified producers.

Cost Control↗
PubMedDate not supplied

The impact of globalization on vaccine development and availability.

Globalization is likely to affect many aspects of public health, one of which is vaccine-preventable communicable diseases. Important forces include increased funding initiatives supporting immunization at the global level; regulatory harmonization; widespread intellectual property rights provisions through the World Trade Organization agreements; the emergence of developing-country manufacturers as major players in vaccine supply; and the appearance of new communicable disease threats, including those potentially linked to bioterrorism. All of these forces can affect, either positively and negatively, the development and availability of vaccines. Harnessing these will be a challenge for policymakers and immunization stakeholders.

Commerce↗
PubMedDate not supplied

Linking pharmacogenetics-based diagnostics and drugs for personalized medicine.

Progress toward personalized medicine in the five years following the sequencing of the human genome has been slower than many expected. We focus on two potential factors that might be important in explaining this disappointing progress: the limitations of genetic prediction and the lack of appropriate economic incentives. Clinical application of DNA-based and other biomarkers is likely to succeed only on a case-by-case basis, depending on such factors as information content of the biomarker, accuracy of current assessment methods, and effectiveness of available interventions. Both strong intellectual property and value-based, flexible pricing systems will be important in making personalized medicine a reality.

Biomarkers↗
PubMedDate not supplied

The market for follow-on biologics: how will it evolve?

With spending on biologics rising and patent expiry approaching for several blockbuster biologics, Congress and the Food and Drug Administration are considering creating a clear pathway for so-called follow-on biologics. Differences between drugs and biologics will affect market outcomes in various ways. Conservative budget impacts are appropriate in the short run because fewer competitors will enter, and average prices will drop less than was the case following the Hatch-Waxman Act. Over the long term, intellectual property provisions will be important considerations for policymakers designing a pathway for follow-on biologics that balances price competition and innovation incentives.

Biological Products↗
PubMed2004

Effect of lactobacilli administration in the vaginal tract of mice: evaluation of side effects and local immune response by local administration of selected strains.

Lactobacilli are the predominant microorganisms in the vaginal tract of human and some homeothermic animals. They can maintain the ecological equilibrium of the tract by protecting against pathogenic microorganisms. In the last few years, there has been an increased tendency to use probiotic microorganisms to restore the ecological equilibrium and to protect against infections. This principle has been widely applied to the gastrointestinal tract. More recently, some other studies have reported the application of probiotics in different tracts, for example, the urogenital or respiratory tract. One of the objectives of our group is to design probiotic products for the urogenital tract. With this purpose, lactobacilli were isolated from the human vagina, and later some of them were selected for their probiotic characteristics (production of antagonistic substances or adhesion capability). The application of probiotic products in the vaginal tract has been approached empirically; some pharmaceuticals containing these microorganisms are available in the United States or Europe or are protected under the patent process or intellectual property rights. There are not enough studies in humans or animals to determine whether their administration can produce some type of collateral or adverse effect. Using Balb/c mice as the experimental model, the object of the present work was to study (1) whether intravaginal administration of human lactobacilli can produce colonization of the tract; (2) whether such administration produces some type of adverse or collateral effect; and (3) whether probiotics are able to stimulate the local immune system. Keeping in mind that hormones can affect the colonization or persistence ability of microorganisms, and with the purpose of having all animals at the same point in the sexual cycle, animals were cycled with estradiol 48 h before inoculation with lactobacilli. They were then inoculated im with hormones 48 h before beginning microorganism inoculations. Later they were intravaginally inoculated with the appropriate dose of each Lactobacillus strains. The animals were sacrificed on different days after inoculation to perform the following studies: 1. Microbiological assays: To determine the number of lactobacilli in the tract (in vaginal washes or in organ homogenates), by plating the samples in selective media containing antibiotic (to differentiate the resident flora from those administered experimentally).

Animals↗
PubMed1998

The Human Genome Project and the role of genetics in health care.

The Human Genome Project, the mapping of our 100,000 genes and the sequencing of all of our DNA, will have major impact on biomedical research and the therapeutic and preventive health care. The tracing of genetic diseases to their molecular causes is rapidly expanding diagnostic and preventive options, while the increased insights into molecular pathways open tremendous perspectives for pharmacological and genetic therapies. The design of animal model systems for the functional study of disease and development of bioinformatics and biostatistics to improve our pattern recognition abilities are greatly accelerating progress. However, the optimal value from the current explosion of 'data mining' possibilities will only be gained when the basic data are made and kept publicly accessible, at the same time preventing the jeopardisation of the protection of intellectual property, arising from downstream inventions. This is one of the goals of HUGO, the international Human Genome Organisation, established 9 years ago to assist coordinating data acquisition and exchange and societal implementation of the genome project. Additional points of major importance in this historic endeavour are the safeguarding of a worldwide balance in the contribution and benefits to countries and population, the prevention of stigmatisation and discrimination of individuals and groups and the maintenance of respect for the priceless diversity of our world's cultures and traditions.

Delivery of Health Care↗
PubMed2003

Techniques patents for SNP genotyping.

Single nucleotide polymorphisms (SNPs) are the most abundant form of genetic variation in the human genome, accounting for more than 90% of all differences between individuals. Many complex phenotypes in humans have a significant genetic component and most of the variability is therefore likely to stem from differences in patterns of SNPs. Association studies involving the large-scale analysis of SNPs can help to identify genes affecting many human phenotype variations, including complex diseases and drug responses. SNPs therefore play a major role in all stages of the drug development process, from target identification through to clinical trials. SNPs are also the basis of pharmacogenomics, the tailoring of medicines to suit an individual's genome. Given the potential impact of SNPs on healthcare, the biotechnology industry has focussed urgently on the development of high-throughput methods for SNP genotyping. All genotyping methods are a mix and match of different allele discrimination and signal detection technologies and as such may represent the intellectual property of several individuals or organizations. In this review, we explore the patent issues surrounding SNP genotyping and how this is influencing large scale, commercially valuable projects involving SNPs.

Genome, Human↗
PubMed2004

Gentronix.

Gentronix is an innovative biotechnology company with the aim of providing cell-based assays and systems to ease or remove some of the current bottlenecks in preclinical drug discovery and development. Gentronix's first product, GreenScreen trade mark GC, is a combined genotoxicity and cytotoxicity test designed for high-throughput screening of new pharmaceutical lead compounds, giving drug development scientists a cost-effective preview of the battery of mandatory regulatory genotoxicity tests. Future products based on the company's extensive intellectual property rights portfolio will combine the company's expertise in cellular biosensor systems with novel optical detection technology to deliver a range of products for other applications within drug discovery, as well as industrial and environmental monitoring of toxic chemicals.

Biosensing Techniques↗
PubMed2004

Ethical concerns about federal approval of risky pediatric studies.

The US Federal Code limits research with healthy children to no more than a minimal risk of harm; it restricts research with children who have some disorder or condition to no more than a minor increase over minimal risk, unless potential harms are offset by potential benefits to them, as in therapeutic studies. Higher risk studies require "407 approval," named after the relevant section of the code describing requirements. Rarely used until recently, 407 approval requirements include Institutional Review Board approval and authorization by the Secretary of the Department of Health and Human Services after consultation with a panel of experts; a period for public comment; and assurances that there are adequate permission, consent, and assent. This 407-approval mechanism contains both procedural and interpretative ambiguities, which raise ethical concerns about 1) the expertise represented on advisory panels, 2) the scope of the information offered to the public for comment and its potential conflicts with investigators' intellectual property or commercial interests, 3) whether any upper level of risk exists, and 4) how it conforms with other policies such as the best interest of the child standard in the law or in medical decision making.

Child↗
PubMed2004

A strategy for obtaining social benefits from the gene revolution.

The strategy described in the present paper offers details about the possibility for Brazil to play a more substantial role in the gene revolution. If successfully applied, the powerful science-based technology currently available in Brazil can contribute to extend the benefits of the gene revolution to the poorest countries, very much like the Green Revolution did in the past, thereby reducing the hunger syndrome which claimed the lives of millions of people in some Asian countries, particularly Pakistan and India, decades ago. In his visit to Brazil in February 2004, Norman Borlaug had the opportunity to witness the success of Brazilian agriculture. At a Conference held at ESALQ - Superior School of Agriculture Luiz de Queiroz in Piracicaba, SP, Brazil, he stated that the 21st century revolution will come from Brazil in the area of agriculture. He also said that reducing hunger is essential for the world to achieve socioeconomic stability. A central question remains unanswered: who will fund this revolution? The FAO 2003-2004 Annual Report listed the barriers preventing the gene revolution from reaching the poorest countries: inadequate regulatory procedures-Intellectual Property Rights and Biosafety, poorly functioning seed delivering systems and weak domestic plant breeding capacity; all are discussed in this paper.

Agriculture↗
PubMed2006

PDT in clinics: indications, results, and markets.

Photodynamic therapy (PDT) is based on the selective light activation of an exogenously given drug to patients. PDT acts mainly on cell membranes either of neovascular endothelial cells or of cancer cells leading to cancer cell death. Six drugs are now marketed based on clinical assays in various indications, which showed a clear cost efficiency as compared to other classical procedures. PDT is easy to handle and can be performed in medical installations fitting the conditions of health care in developing countries. Its cost effectiveness could represent an appropriate solution to the increasing number of cancers of various origin. However despite all the clinical results now available, PDT development remains slow. The reasons for this situation include cost of development, intellectual property, and competition between pharmaceutical companies.

Ambulatory Care Facilities↗